Galmed-Aramchol

Condition: Nonalcoholic steatohepatitis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Confirmation of nonalcoholic steatohepatitis on a diagnostic liver biopsy
  • Total NAFLD Activity Score (NAS) of four or more with at least one in each component of the NAS score
  • Fibrosis stage must be 2 or 3

Key Exclusion Criteria

  • Documented liver cirrhosis (fibrosis stage 4)
  • Inability or unwillingness to undergo a liver biopsy
  • Abnormal synthetic liver function

Full Study Name

A Phase III-IV, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) The ARMOR Study (IRB no. 00000251)

Summary

This study focuses on individuals diagnosed with nonalcoholic steatohepatitis (NASH) who are overweight or obese and who have prediabetes or Type 2 diabetes. NASH is a chronic liver disease that may cause scarring of the liver and liver failure. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called aramchol on NASH and NASH-related complications compared to placebo (inactive substance). 

Previous studies have shown that aramchol may be an effective treatment for NASH, as it may reduce the amount of fat stored in liver cells and potentially reduce or prevent disease progress, including liver damage and scarring. Participants will be randomly assigned to receive either aramchol or placebo.

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